Kornimate/medical-research-clean huggingface dataset:
biofeedback training to control pain processing

Conditions: Pain

Summary: the purpose of this study is to test whether a novel form of biofeedback training can help individuals regulate their pain more effectively.

relaxation is a low-cost treatment for managing pain with little or no side effects. the proposed study will use a novel biofeedback procedure to try to enhance the ability of relaxation to engage pain inhibition. specifically, a biofeedback system will be used to provide training in conditioned pain regulation. the biofeedback system will monitor the trainee's level of sympathetic arousal and use it to control the intensity of painful stimulations delivered to the trainee during biofeedback. so when the trainee successfully relaxes (and reduced arousal), the intensity is lowered and produces pain relief. efficacy of the training will be tested in a randomized controlled trial in which healthy, pain-free trainees are assigned to receive 3 training sessions or 3 sessions of a control procedure (2 other procedures will serve as controls; 3 groups total). the aim will be to assess whether the training results in inhibition of experimental pain and the nociceptive flexion reflex (nfr, a physiological marker of spinal pain signaling) to determine whether brain-to-spinal cord inhibitory circuits are engaged.

Eligibility criteria:
inclusion criteria: * healthy pain free individuals over the age of 18. exclusion criteria: * under 18 years of age (given the nature of the study) * history of serious cardiovascular, neuroendocrine, or neurological disorders * hypertension (due to a relationship between blood pressure and pain);5 4) history of chronic pain * current opioid, antidepressant, or anxiolytic medication use * psychosis or apparent cognitive impairment * body mass index\>35 (due to difficulty eliciting an nfr in persons with high adiposity) * inability to understand and read english (questionnaires and consent form are in english) * recent use of an over-the-counter pain medication (within the last 24 hours) or narcotic medication (within the last two weeks) * history of panic attacks. no one will be excluded based on ethnic, racial, or gender characteristics.
efficacy and safety of ranibizumab (intravitreal injections) versus laser treatment in patients with visual impairment due to diabetic macular edema

Conditions: Diabetic Macular Edema; Visual Impairment

Summary: this study will assess the efficacy and safety of ranibizumab (intravitreal injections) versus laser treatment in patients with visual impairment due to diabetic macular edema.


Eligibility criteria:
inclusion criteria: 1. diabetes mellitus 1 or 2, hba1c \< 11.0%, with: clinically significant diabetic macular edema in at least one eye. 2. previous treatment with macular photocoagulation only should be considered if the investigator believes that the study eye may possibly benefit from additional photocoagulation. 3. best corrected visual acuity score between 78 and 25 letters (early treatment diabetic retinopathy study- etdrs chart - 4 meters). 4. central foveal thickness \>250µm (optical coherence tomography). 5. diabetes medication stable in the 3 months prior. exclusion criteria: in the study eye: 1. active intraocular inflammation. 2. any active infection. 3. history of uveitis. 4. structural damage within 500 microns of the center of the macula. 5. neovascularization of the iris. 6. uncontrolled glaucoma in either eye (intraocular pressure \> 24 mmhg). other protocol-defined inclusion/exclusion criteria may apply.

Keywords: diabetic macular edema ranibizumab laser treatment visual impairment
a study comparing eribulin mesylate and ixabepilone in causing or exacerbating neuropathy in participants with advanced breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study in patients with advanced breast cancer is to compare the incidence and severity of neuropathy adverse events for the two treatment groups (eribulin versus ixabepilone) using national cancer institute common terminology criteria for adverse events (nci ctcae version 3.0) grading.


Eligibility criteria:
inclusion criteria: 1. female subjects with confirmed locally recurrent or metastatic carcinoma of the breast who have received prior taxane therapy and at least one prior cytotoxic chemotherapy regimen for advanced disease. exclusion criteria: 1. subjects who have received prior ixabepilone therapy. 2. subjects with prior participation in an eribulin clinical study, even if not assigned to eribulin treatment. 3. subjects with pre-existing neuropathy grade greater than or equal to 2. 4. subjects with a history of diabetes mellitus type 1 or 2. 5. subjects with bilateral mastectomy which included bilateral axillary lymph node dissection. 6. subjects with missing digits required for vibration assessment. 7. subjects with any other concurrent diseases or conditions that would be expected to interfere with neuropathy assessments, which may include vitamin deficiency, sequelae of cerebrovascular disease, thyroid insufficiency, lumbar or cervical radiculopathy, or alcoholic or inflammatory neuropathy.

Keywords: breast cancer oncology
selective versus routine shunting in carotid endarterectomy patients

Conditions: Stenoses, Carotid Artery

Summary: the project involves prospectively randomizing patients to either routine carotid shunting or selective carotid shunting during carotid endarterectomy (cea) under general anesthesia (ga) to see the difference in post-op complications and occurence rates. patients will be randomized to routine shunt vs selective groups.

the significance extends to all surgeons who perform carotid endarterectomy because of their desire to improve patient care by decreasing the overall perioperative complication rate of the procedure by selectively not shunting those patients who ideally do not require it and thus eliminating the attendant morbidity associated with it. the hypothesis is that there will be no difference in patient outcomes (death, minor strokes, major strokes, transient ischemic attack (tia)) for patients undergoing a carotid endarterectomy with a sp of \> 50 mm hg using selective shunting.patients will be randomized to routine shunt vs selective groups. in selective shunt, there will be subgroup analysis to measure % stenosis if the systolic pressure is \< 40mmhg calling it as shunt group. all patients in the study, irrespective of treatment group will be followed post-operatively from 24 hours to 30 days. the patient will be monitored and the following outcomes documented - death, minor stroke, major stroke, trans-ischemic attack (tia).

Eligibility criteria:
inclusion criteria: * patients with a sp \>= 50 mmhg will be randomized to receive a shunt or not receive a shunt. exclusion criteria: * patients that will be excluded are those who present for a redo cea, have had a coronary artery bypass graft (cabg), permanent stroke, and or a contralateral artery total occlusion of \> 30%. * finally, consented patients with a stump pressure of \<= 50 mm hg will be excluded from the study and receive standard of care.
a study of gw842166 in adults with osteoarthritis pain

Conditions: Osteoarthritis, Knee

Summary: the purpose of this study is to determine whether gw842166 is effective in the treatment of osteoarthritis pain of the knee.


Eligibility criteria:
inclusion criteria: * male or female outpatient, \>= 40 years of age * meets acr clinical and radiographic criteria for classification of idiopathic (primary) osteoarthritis of the knee with symptom duration for at least 3 months * meets ara functional status requirements * meets womac pain subscale score requirements * has taken analgesics for the treatment of their knee oa for at least 4 out of 7 days in each of the 4 weeks preceding screen exclusion criteria: * any pre-specified clinical/biological/ecg abnormality * any pre-specified drug sensitivity * history of peptic ulceration or gi bleeding * use of protocol-specified medications * secondary cause of knee oa * lower extremity surgery within 6 months of screening * use of analgesics other than allowed per protocol * use of corticosteroids or hyaluronan outside of allowed window prior to screening

Keywords: osteoarthritis, knee, gw842166, pain, efficacy, safety
seoul national university airway registry

Conditions: Chronic Obstructive Pulmonary Disease (COPD); Asthma; Asthma With Chronic Obstructive Pulmonary Disease; Bronchiectasis; Inactive Tuberculosis of Lung; Chronic Obstructive Airway Disease

Summary: this is a multicenter, prospective observational cohort study, in which patients with chronic airway diseases including chronic obstructive pulmonary disease(copd), asthma, asthma-copd overlap syndrome (acos) will be recruited.


Eligibility criteria:
copd inclusion criteria: * postbronchodilator fev1/fvc \< 0.7 and chronic respiratory symptom exclusion criteria: - asthma inclusion criteria: * never smoker or \<5py of smoking history and recurrent episodes of asthma symptoms (wheezing, dyspnea, chest tightness, cough) and (either positive bdr or positive metacholine/mannitol/exercise provocation test) exclusion criteria: - acos inclusion criteria: * copd and asthma (regardless of smoking status) exclusion criteria: -

Keywords: copd asthma acos bronchiectasis
high-dose atorvastatin for vascular wall protection in thrombectomy patients

Conditions: Mechanical Thrombectomy; Acute Ischemic Stroke

Summary: this project investigates the impact of statins on cerebral vascular wall damage after mechanical thrombectomy. the investigators will undertake a multi-center, prospective, parallel-controlled, open-label, superiority randomized controlled study based on past research on intense lipid-lowering intervention trials. patients undergoing post-thrombectomy will be divided into two groups: the test group and the control group. after surgery, the test group will be given a high dose of atorvastatin (80mg/day), followed by a standard dose (20mg/day). the control group will continue to receive the standard dose of atorvastatin (20mg/day). the investigators will compare the high-resolution vascular wall mri characteristics (vascular wall enhancement, lumen stenosis rate, and so on) within 3-5 days of the operation, as well as the composite incidence of ischemic stroke, transient ischemic attack, intracranial hemorrhage 1 month postoperatively, and the modified rankin score at 90 days.


Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of acute ischemic stroke; 2. with anterior circulation acute stroke who meet and receive emergency endovascular treatment; 3. cta or dsa confirms anterior circulation intracranial arterial lesions, including mt of intracranial arteries (middle cerebral artery (mca), internal carotid artery (ica), basilar artery and/or vertebral artery and p1 segment of posterior cerebral artery (pca); 4. recanalization of blood vessels after operation (mtici ≥ 2b grade) exclusion criteria: 1. placing permanent stents or other implants in the target artery 2. can not receive hr-vwi examination of 3t mri due to claustrophobia or unstable condition 3. contraindications to mri and/or intravenous gadolinium
to assess the efficacy of citruslim® on body composition as well as metabolic and hormonal factors in overweight and obese individuals

Conditions: Overweight and Obesity

Summary: citruslim® can promote healthy weight loss by promoting anabolic state during weight loss programs, prevent the body from storing fat, reduce appetites and maintain healthy cholesterol and blood glucose level during weight loss program. this study focuses to prove the efficacy and safety of the product in a population of overweight and obese individual.


Eligibility criteria:
inclusion criteria: 1. male and female participants with the age of ≥18 and ≤ 60 years of age. 2. bmi of ≥25 - ≤ 35 kg/m2 3. waist circumference:india: men: \> 94 cm (37 inches), women: \>80 cm (31.5 inches) usa: men: \> 102 cm (40 inches), women: \>89 cm (35 inches) 4. triglycerides \>150 mg/dl 5. blood pressure: systolic: ≥130 mm hg and/or diastolic: ≥85 mm hg 6. fasting blood glucose ≥ 100 mg/ dl 7. low hdl level: men: \< 40 mg/dl, women: \< 50 mg/dl 8. ready to give voluntary, written, informed consent to participate in the study. exclusion criteria: participants meeting any of the following criteria will be excluded from the trial: 1. current smoker. 2. inability to walk independently. 3. presence of unstable, acutely symptomatic, or life-limiting illness. 4. neurological conditions causing functional or cognitive impairments 5. unwillingness or inability to be randomized to one of three intervention groups. 6. bilateral hip replacements. 7. exposure to any non-registered drug product within 3 months prior to the screening visit. 8. unable/unwillingness to complete study specific diaries (digital/paper-based).
infiltration or nerve blocks in addition to adductor canal block

Conditions: Gonarthrosis; Total Knee Arthroplasty

Summary: the aim of this study is to evaluate the analgesic efficacy of this quadruple sensory block compared with the currently recommended procedure (adductor canal block + infiltration).

in addition to the adductor canal block, this quadruple block incorporates : 1. the block of the lateral cutaneous nerve of the thigh (or femoral-cutaneous nerve), which is a collateral sensory branch of the posterior part of the lumbar plexus. 2. ipack (infiltration between popliteal artery and capsule of knee), designed as a motor-sparing technique (targeting the sensory articular branches of the sciatic nerve and avoiding the motor branches of the tibial and fibular nerves), is particularly effective on posterior pain. 3. obturator nerve block, a mixed nerve originating from the anterior part of the lumbar plexus. it divides into two branches: anterior, which innervates the adductor longus, adductor brevis and gracilis muscles, and posterior, which innervates the medial part of the knee joint and the posteromedial part of the thigh. it provides sensitivity to the medial aspect of the thigh.

Eligibility criteria:
inclusion criteria: * adult male or female * patient with signed consent to participate in the study, * patient with uni or bilateral primary gonarthrosis * indication for total knee arthroplasty. exclusion criteria: * history of knee fracture, arthroplasty or osteotomy * known or unknown contraindication to alr or locoregional anesthesia products * neurological disease, stroke sequelae * mental deficiency or any other reason that may hinder understanding or strict application of the protocol * patient not affiliated to the french social security system * patient under court protection, guardianship or curatorship * pregnant or potentially pregnant women (women of childbearing age without effective contraception) * patient already included in another therapeutic study protocol
phenotype of headache and facial pain in upper respiratory tract infections

Conditions: Upper Respiratory Tract Infections

Summary: the goal of this longitudinal study is to assess headache and facial pain features in patients with upper respiratory tract infections (urti). the main question it aims to answer are: 1. what is the phenotype of headache / facial pain in urtis 2. does the above mentioned phenotype is associated with: 1. aetiologic factor (virus), 2. type of urti 3. headache/facial pain experienced by patients in the past. participants will: * answer standardized questions, * undergo physical examination, * have a swab test performend for antigens of common viruses causing urti.


Eligibility criteria:
inclusion criteria: * urti confirmed by primary care physician * informed consent to participate in the study exclusion criteria: * chronic or recurrent upper respiratory tract disorders * neoplasms * signs or symptoms of a serious neurologic or psychiatric disorder.
rehabilitation by effort for patients with advanced bronchial cancer

Conditions: Bronchial Cancer; Malignant Mesothelioma

Summary: bronchopulmonary cancers or mesothelioma are associated with effort deconditioning due to pathology (chronic inflammation) and also to treatments (surgery, radiotherapy, chemotherapy); it's considerably alters patients quality of life. investigators want to ensured the feasibility of rehabilitation by effort for these patients.


Eligibility criteria:
inclusion criteria: * general condition according to world health organisation 0-1 * age between 18 and 70 years old * non progressive patients according to recist criteria 1.1 after chemotherapy treatment whichever line of treatment * autonomous patient * voluntary written informed consent signed * patients with social security insurance exclusion criteria: * bone metastasis with fracture risk * significant cardiovascular pathology * cardiac, vascular, rheumatologic or neurologic contraindication * patients living far 60 kms from toulouse * patients under juridical protection guardianship, or tutelage measure

Keywords: bronchial cancer rehabilitation
ofatumumab in portuguese multiple sclerosis patients - an observational study

Conditions: Relapsing Multiple Sclerosis

Summary: this non-interventional study will compare the effect of ofatumumab treatment between patients that began ofatumumab within the 3 years after multiple sclerosis diagnosis and patients that began ofatumumab with more than 3 years of multiple sclerosis diagnosis in a real-world setting in portugal.

this is a 2 cohort, multi-center, observational study carried out in portugal that aims to describe the effectiveness of ofatumumab in a setting of routine medical care. primary data will be collected from multiple sclerosis patients who initiate ofatumumab early and later in their disease (cohorts 1 and 2, respectively). data will be collected during 3 visits distributed over a maximum period of 24 months. exceptionally, if the patient shows expanded disability status scale (edss) worsening in visit 2 or 3 (12 and 24 months after ofatumumab initiation, respectively), there will be an additional visit 6±1 months after visit 2 or 3 for edss confirmation. the study includes patients that have initiated ofatumumab up to 12 months prior inclusion in the study or patients that are initiating ofatumumab at the moment of study inclusion. patients in both cohorts will have to be treated with ofatumumab for at least two years to compare no evidence of disease activity (neda)-3 at 12 to 24 months, respectively.

Eligibility criteria:
inclusion criteria: to participate in the study, all the following inclusion criteria must be met: * patients aged 18 years or older * written informed consent obtained before participating in the study. * patient is willing and able to complete the assessments, including pro questionnaires, as outlined in this study. * diagnosis of rms per mcdonald criteria (2017) occurred prior to initiation of ofatumumab. * treatment with ofatumumab is in accordance with the portuguese indication of kesimpta® (i.e., treatment of adult patients with relapsing multiple sclerosis (rms) with active disease defined by clinical or imaging features). * patients that have initiated ofatumumab up to 12 m prior inclusion in the study or patients that are initiating ofatumumab at the moment of study inclusion. exclusion criteria: to participate in the study, none of the following exclusion criteria must be met: * use of investigational drugs during the study, or between ofatumumab initiation and inclusion into the study, or within 5 half-lives of investigational drug before ofatumumab initiation, or until the expected pharmacodynamic effect has returned to baseline, whichever is longer. * use of high efficacy therapy (including ocrelizumab, natalizumab, mitoxantrone, rituximab and alemtuzumab) in both cohorts prior to the initiation of ofatumumab.

Keywords: relapsing multiple sclerosis rms ofatumumab nis portugal
asthma education and emergency department visits by asthmatic children

Conditions: The Frequency of ER Visits in Asthmatic Children

Summary: this study will be conducted to evaluate the effects of an educational asthma program on the frequency of emergency department visits and identifying factors associated with frequent emergency department visits by asthmatic children and determine its effect on asthma severity and quality of life among asthmatic children and their caregivers.

this one-arm interventional clinical trial study will be conducted at pediatric chest clinics and the emergency department of the children's hospital of ain shams university located in cairo during the period from september 2021 to the end of december 2021. the study will be conducted on 30 asthmatic pediatric patients aged from 1-15 years old with documented asthma diagnoses (intermittent wheezes, breathlessness, dry cough, etc) inclusion criteria: : objective asthma diagnostic testing consists of 2 components: (1) demonstration of airway obstruction and (2) documentation of variability in the degree of obstruction. exclusion criteria: 1. underlying chronic lung diseases like: (cystic fibrosis, tuberculosis, childhood interstitial lung diseases). 2. asthmatic patients with major systemic illness (diabetes, chronic renal failure, chronic liver disease). all the study participants will be subjected to an educational asthma program for 3 months to provide parents and children with information and skills to manage their asthma, through avoiding triggers, training in the correct use of medicines, including inhaler technique, information, and support to maximize adherence. all patients will be followed up by a phone call every 2 weeks and a follow-up visit monthly to confirm compliance with the educational program.

Eligibility criteria:
inclusion criteria: * children with a documented asthma diagnosis children aged from 1 to 15 years exclusion criteria: * children with underlying chronic lung diseases

Keywords: asthma, pediatric, education
clinical study of the tympanostomy tube delivery system

Conditions: Otitis Media With Effusion

Summary: the objective of this investigational study is to evaluate the safety and performance of the acclarent tympanostomy tube delivery system (ttds) for the placement of the tympanostomy tube \[tt(s)\] in patients indicated for such treatment for chronic otitis media with effusion (ome) or recurrent acute otitis media (aom).


Eligibility criteria:
inclusion criteria: 1. patients scheduled to undergo bilateral or unilateral tympanostomy tube insertion. 2. either male or female exclusion criteria: 1. history of sensitivity or reaction to anesthesia chosen for the procedure 2. markedly atrophic, mono- or bimeric, severely retracted, atelectatic or perforated tympanic membrane 3. otitis externa 4. active acute otitis media 5. otitis media pathology 6. stenosed ear canal